ACTRN12607000631404
Terminated
Phase 4
A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion for the prevention of uterine atony and post partum haemorrhage at elective caesarean section.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Postpartum haemorrhage
- Sponsor
- Monash University
- Enrollment
- 948
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnancy: Singleton only Fetus: Alive only Gestation: 37 weeks \- 41 weeks Surgery: Elective lower segment caesarean section Anaesthesia: Regional anaesthesia (spinal, epidural, combined spinal epidural (CSE)) Past medical history: No significant maternal medical or obstetric disorders Parity: \<3 (equal to or less than 3\): Pre\-op Haemoglobin: Hb \> (equal to or more than) 100g/dl Language: Fluency in English Age: \>18 years of age (equal to or more than)
Exclusion Criteria
- •Active labour (presence of regular uterine activity accompanied by cervical dilation)
- •Emergency caesarean section
- •General anaesthesia
- •(Less than) \<37 completed weeks of pregnancy
- •Fetal demise
- •Multiple pregnancy
- •Polyhydramnios
- •Macrosomic fetus (Estimated fetal weight EFW \>4\.5 kg)
- •Past history of post partum haemorrhage 'PPH' requiring additional measures
- •Antepartum haemorrhage (requiring hospitalisation)
Outcomes
Primary Outcomes
Not specified
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